Active — Not RecruitingPhase 2

Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study

United States, Canada194 participantsStarted 2022-04-20

Plain-language summary

This phase II trial compares the usual treatment of radiation therapy alone to using the study drug, relugolix, plus the usual radiation therapy in patients with castration-sensitive prostate cancer that has spread to limited other parts of the body (oligometastatic). Relugolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body. It may stop the growth of cancer cells that need testosterone to grow. Radiation therapy uses high-energy x rays or protons to kill tumor cells. The addition of relugolix to the radiation may reduce the chance of oligometastatic prostate cancer spreading further.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of prostate adenocarcinoma at any anatomical location (for example, prostate, metastatic site), including intraductal or ductal carcinoma, at any time before registration * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 180 days prior to registration * Prior curative-intent treatment to the prostate, by either: * External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites * Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes. * Note: Patients who have received curative intent with radiation prior to prostatectomy are eligible and should be categorized as RT to Intact Prostate since that was the first curative intent * Must meet study entry criteria based on the following diagnostic workup within 120 days prior to registration: * History and physical examination; * Fluciclovine or PSMA PET scan; * PET must be combined with either CT or MRI, but a diagnostic CT or MRI reading/interpretation is not required * 1 - 5 oligometastatic lesions in bone and/or nodal/soft tissue (non-abutting nodes are counted separately) sites on fluciclovine or PSMA PET within 180 days prior to registration and includes at least ONE of the foll…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Radiological progression-free survival (rPFS)

Timeframe: Time from randomization to the occurrence of radiological progression detected by conventional imaging or death from any cause, assessed up to 5 years

Trial details

NCT IDNCT05053152

SponsorNRG Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-02-01

View on ClinicalTrials.gov More Oligometastatic Prostate Carcinoma trials